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Single and Multiple Ascending Dose and Food Effect PK Study in Healthy Adult and Elderly Subjects

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ClinicalTrials.gov Identifier: NCT03668314
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : October 17, 2018
Sponsor:
Collaborator:
QPS Netherlands B.V.
Information provided by (Responsible Party):
Rodin Therapeutics

Brief Summary:
A three (3) part study to evaluate the safety, tolerability and PK of RDN-929

Condition or disease Intervention/treatment Phase
Healthy Drug: RDN-929 Drug: Placebo oral capsule Drug: RDN-929 TBD dose Phase 1

Detailed Description:

Part 1 (Randomized, Double Blind):

Up to 6 single ascending doses of RDN-929 are planned to be tested in 6 cohorts of 8 healthy males (Cohort 1:1 to 1:6). Within each cohort subjects will be randomly assigned to receive either a single dose of RDN-929 (6 subjects) or matched placebo (2 subjects).

Part 2 (Open):

Part 2 will consist of 2 crossover treatment periods in one cohort of 12 healthy elderly subjects (at least 3 of each gender), aged 55-80 years. The treatments will be separated by a washout period of at least 7 days. The dose selected for this part of the study will be based on the results of Part 1.

In Period 1, subjects will be randomized to receive a single dose of RDN-929 in either fasted or fed status. In Period 2, subjects will receive a single dose of RDN-929 under the alternate status.

Part 3 (Randomized, Double Blind):

Multiple ascending doses (MAD) of RDN-929 are planned to be tested in up to 4 cohorts of 8 healthy elderly subjects (at least 3 of each gender per dose level cohort), aged 55-80 years. The doses will be selected by the safety review committee (SRC) based on all available safety, tolerability and PK data and after approval by the ethics committee.

Within each cohort subjects will be randomly assigned to receive either, RDN-929 once daily (6 subjects) or matched placebo (2 subjects) once daily for 12 days. Escalation to the next higher dose level will be based upon a review of the safety and tolerability data.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parts 1 and 3 are parallel designs with escalating doses within each part. Part 2 is a FE cross-over study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single and Multiple Doses of Orally Administered RDN-929 in Healthy Adult and Elderly Subjects
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : July 1, 2019

Arm Intervention/treatment
Experimental: Cohort 1:1 - 1:6 RDN-929
RDN-929 single dose capsule
Drug: RDN-929
Single dose from 2 mg to TBD

Placebo Comparator: Cohort 1:1 - 1:6 placebo
Placebo single dose capsule
Drug: Placebo oral capsule
Matching placebo Single dose

Experimental: Cohort 2:1
Fed/Fast RDN-929
Drug: RDN-929 TBD dose
Fed vs fast dose TBD based upon results of previous cohorts

Experimental: Cohort 3:1- 3:4 RDN-929
RDN-929 multiple dose capsules once daily for 12 days
Drug: RDN-929
Multiple dose based on results of previous cohorts

Placebo Comparator: Cohort 3:1- 3:4 placebo
placebo multiple dose capsules once daily for 10 days
Drug: Placebo oral capsule
Matching placebo multiple dose




Primary Outcome Measures :
  1. Number of subjects with adverse events [ Time Frame: Screening to end of study, up to 7 weeks ]
    Listing and summary of AE incidence

  2. Number of subjects with Physical exam findings [ Time Frame: Screening to end of study, up to 7 weeks ]
    Listing of clinically significant changes in PE findings

  3. Number of subjects with Clinical safety lab changes [ Time Frame: Screening to end of study, up to 7 weeks ]
    Listing and change from baseline to end of study

  4. Number of subjects with Systolic blood pressure changes [ Time Frame: Screening to end of study, up to 7 weeks ]
    Listing and change from baseline to end of study

  5. Number of subjects with Heart rate changes [ Time Frame: Screening to end of study, up to 7 weeks ]
    Listing and change from baseline to end of study

  6. Number of subjects with 12 Lead ECG changes [ Time Frame: Screening to end of study, up to 7 weeks ]
    Change in 12-lead ECG parameters from baseline to end of study

  7. Number of subjects with 3 Lead ECG findings [ Time Frame: Predose to 8 hours post dose on Day 1 (Parts 1 and 2) and Days 1 and 12 (Part 3) ]
    Listing of findings

  8. Number of subjects with C-SSRS changes [ Time Frame: Baseline to end of study (Part 3 only), up to 7 weeks ]
    Listing of results

  9. Number of subjects with Visual analogue scale changes [ Time Frame: Baseline to end of study for Part 1 and 3, up to 7 weeks ]
    VAS for headache and nausea


Secondary Outcome Measures :
  1. Maximum observed plasma concentration, Cmax [ Time Frame: Predose to 48 hours post first and last dose, up to 2 days (Parts 1 and 2) and 2 weeks (Part 3) ]
    Of RDN-929 and primary metabolite

  2. Time to reach maximum observed plasma concentration, Tmax [ Time Frame: Predose to 48 hours post first and last dose, up to 2 days (Parts 1 and 2) and 2 weeks (Part 3) ]
    Of RDN-929 and primary metabolite

  3. Area Under the plasma concentration time curve, AUC [ Time Frame: Predose to 48 hours post last dose, up to 2 days (Parts 1 and 2) and 2 weeks (Part 3) ]
    Of RDN-929 and primary metabolite



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy as determined by the Investigator, based on a medical evaluation including medical history physical examination, neurological examination, laboratory tests and cardiac monitoring
  • Men, age 18-54 years inclusive at Screening (Part 1) or men and postmenopausal or surgically sterile women age 55-80

Exclusion Criteria:

  • Any history of major psychiatric disorders, including substance use disorders, according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.
  • Acute suicidality or history of suicidal behavior.
  • Alanine aminotransferase or aspartate aminotransferase levels greater than 1.5 times the upper limit of normal (ULN) at Screening. One retest is allowed.
  • A corrected QT interval measurement corrected according to the Fridericia rule (QTcF) > 450 msec during controlled rest at screening or between screening and first dose administration, or family history of long QT syndrome.
  • Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any abnormalities in the 12-lead ECG that, in the judgement of the Investigator or Medical Monitor, may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology or left ventricular hypertrophy.
  • A clinically significant vital signs abnormality at screening or between screening and first dose administration. This includes, but is not limited to, the following, in the supine position: (a) systolic blood pressure < 90 or >150 mmHg, (b) diastolic blood pressure <50 or > 95 mmHg, or (c) heart rate < 45 or >100 beats per minute.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668314


Contacts
Contact: Floor Morrien 31503048000 floor.morrien@qps.com

Locations
Netherlands
QPS Netherlands B.V. Recruiting
Groningen, Netherlands
Contact: Principal Investigator         
Sponsors and Collaborators
Rodin Therapeutics
QPS Netherlands B.V.
Investigators
Principal Investigator: PI QPS

Responsible Party: Rodin Therapeutics
ClinicalTrials.gov Identifier: NCT03668314     History of Changes
Other Study ID Numbers: RDN-929-101
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No